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Spots Global Cancer Trial Database for Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

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Trial Identification

Brief Title: Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Official Title: Neoadjuvant Dupilumab in Men With Localized High-Risk Prostate Cancer

Study ID: NCT03886493

Conditions

Prostate Cancer

Interventions

Dupilumab

Study Description

Brief Summary: This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy.

Detailed Description: This is a single-center, single arm, open-label phase II study evaluating the safety, anti-tumor effect, and immunogenicity of neoadjuvant Dupixent given prior to radical prostatectomy in men with high-risk localized prostate cancer (this trial will enroll men with at least high risk prostate cancer defined by NCCN Guidelines Version 2.2017 = clinical stage ≥T3a or PSA \>20 ng/mL or Gleason score ≥8). Patients will be recruited from the outpatient Urology clinic. Men will be treated with dupilumab 600 mg subcutaneously (SQ) on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43. They will then undergo surgery on day 57. 14 days after the last dose of Dupixent, prostate glands will be harvested at the time of radical prostatectomy, and prostate tissue will be examined for the secondary endpoints. Follow-up evaluation for adverse events will occur 30 days and 60 days after surgery. Patients will then be followed by their urologists according to standard institutional practices, but will require PSA evaluations every 3 (±1) months during year 1 and every 6 (±2) months during years 2-3.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore, Maryland, United States

Contact Details

Name: Kenneth Pienta, MD

Affiliation: Johns Hopkins University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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